National Medical Device eAlert System

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A newly developed National Medical Device eAlert System designed to streamline the management of medical device safety notices within the public health system was launched at the Royal College of Physicians in Ireland on November 30th.  Developed by the HSE National Medical Devices Equipment Management Committee, in collaboration with the Quality Improvement Division (QID) and with assistance from the Health Products Regulatory Authority (HPRA), the aim of the eAlert system is to provide each HSE or HSE-funded voluntary service location assurance in the management of medical device safety or quality related notices issued by the HPRA.

The occasion also saw the launch of a HSE Medical Device Management ‘Quality Assessment and Improvement Tool (QA+I tool)’ to facilitate assessment against the HSE Medical Device Equipment Management Policy and Best Practice Guidance.  A key component of the medical device vigilance system is the dissemination of information, which may be used to prevent recurrence of an incident or to alleviate the consequences of such incidents.  As the national competent authority for medical devices, the HPRA publishes notices relating to the safety and/or quality of medical devices on its website www.hpra.ie. The majority of these notices are for the attention of health professionals including those working in hospitals, community healthcare organisations and other health facilities.

The national eAlert system receives notification directly from the HPRA of all safety notices or any internally generated HSE safety notifications for distribution.  A priority level is assigned to each alert in accordance with the HPRA traffic light system of red (Priority 1, most urgent), amber (Priority 2) and green (Priority 3, least urgent).  The medical devices eAlert system has been implemented and is available throughout the HSE and voluntary hospitals. T he web-enabled system is hosted by the HSE’s ICT centre and will facilitate the nomination of a ‘designated person / vigilance officer’ within hospitals, community healthcare organisations and other health facilities to take responsibility for the receipt of the medical device alert notifications. The ‘designated person / vigilance officer’ will ensure the further internal facility distribution to the relevant personnel for implementation of the recommended actions where applicable.  An automated response timescale (associated with the priority level) is also assigned by the HSE to each notification within which the relevant action must be reported back by the designated person / vigilance officer to the central ICT system as having been completed, or not being applicable, or some other outcome was required.  The eAlert system provides for an extremely efficient method of disseminating safety information to key medical device users and will contribute to enhanced patient safety across all the health facilities involved.

Healthcare professionals and medical device users are reminded to remain vigilant for field safety notices issued by medical device manufacturers as these will not be circulated via the eAlert system. The HPRA will continue to upload a monthly summary of field safety notices known to affect the Irish market on the website www.hpra.ie. As part of its ongoing work to encourage user reporting, the HPRA in collaboration with the QID and Medical Device Equipment Management Committee developed a Step-by Step guide to facilitate users in reporting medical device adverse events.  This guide was also launched on November 30th and will be circulated to all users in the Acute Service and the Community Healthcare Organisation in early 2016.  Relevant guidance is available for download from www.hpra.ie.